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Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02676375
Recruitment Status : Completed
First Posted : February 8, 2016
Results First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Information provided by (Responsible Party):
Arthur Brody, Brentwood Biomedical Research Institute

Brief Summary:
The study investigators will enroll 45 treatment seeking, cigarette smokers with a Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly assigned into three arms of treatment for smoking cessation treatment, receiving either 1. Control: "standard therapy" (n=15), including stepwise monotherapy of nicotine patch or bupropion sustained release, 2. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months (n=15), or 3. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months with home visits (n=15) and phone calls to the home or living facility. During all treatments, participants will receive weekly smoking cessation group counseling, as is standard for smoking cessation treatment. At the time of enrollment, participants will complete a one-study visit lead-in to complete baseline assessments, psychological and medical evaluation, and comprehensive assessment of drug use to determine study eligibility. Once determined to be eligible for the trial, participants will be randomly assigned to one of the treatment arms using a randomization procedure. The "standard therapy" treatment arm, or control group, will receive either nicotine patch taper starting at 21 milligrams (mg) daily, nicotine lozenge as needed, and/or bupropion sustained release at 150mg daily for 3 days, then 150 mg twice a day for a total of 12 weeks. The extended therapy arm will start the nicotine patch at 21mg daily with as needed nicotine lozenge for breakthrough cravings and initiation of bupropion sustained release at 150mg daily for 3 days a week prior to starting nicotine replacement, then 150 mg twice daily for 6 months (as tolerated). The third arm will be identical to the second arm except for the added home visit intervention.

Condition or disease Intervention/treatment Phase
Smoking Cessation Schizophrenia Drug: Combination Bupropion + NRTs Other: Extended Treatment Other: Home Visits & Calls Drug: Monotherapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment
Study Start Date : January 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Standard Monotherapy
Treatment as usual starting with one smoking cessation medication plus group therapy.
Drug: Monotherapy
Experimental: Combination Extended Treatment
Extended treatment with multiple standard medications plus group therapy.
Drug: Combination Bupropion + NRTs
Other: Extended Treatment
Experimental: Combination Extended Treatment + Home Visits/Calls
Extended treatment with multiple standard medications plus group therapy plus home visits.
Drug: Combination Bupropion + NRTs
Other: Extended Treatment
Other: Home Visits & Calls

Primary Outcome Measures :
  1. Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM) [ Time Frame: Measured week 0, 12, and 26 ]
    Weekly measurements of expired carbon monoxide in the units of parts per million (PPM) participants to evaluate abstinence from smoking (a value equal to or less than 3 PPM is considered abstinent).

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Veterans 21 years of age or older;
  2. meet DSM-IV criteria for Schizophrenia or Schizoaffective disorder based on clinical interview
  3. meet DSM-IV criteria for nicotine dependence
  4. must report smoking >10 cigarettes daily and positive CO exhalation >8ppm
  5. seeking treatment for nicotine dependence;
  6. willing and able to comply with study procedures;
  7. willing and able to provide written informed consent;
  8. if female, not pregnant or lactating and willing to use a medically reliable method of birth control during the trial (e.g., birth control pills, Depo-Provera, and/or condoms with spermicide).
  9. Must be clinically stable (i.e., no inpatient hospitalizations for 3 months prior to enrollment, no changes in medication in the four weeks prior to enrollment)

Exclusion Criteria:

  1. current or past history of cardiovascular disease including myocardial infarction, acute coronary syndrome, angina pectoris, coronary artery disease, atrial fibrillation/flutter, cor pulmonale, arrhythmia other than sinus tachycardia or sinus bradycardia, or an EKG suggesting any of these;
  2. systolic blood pressure greater than 160 or diastolic blood pressure greater than 100 (i.e. cutoffs for stage 2 hypertension)
  3. a history of angioedema;
  4. renal impairment (CrCl < 50);
  5. a current neurological disorder (e.g., organic brain disease, dementia) or a medical history which would make study agent compliance difficult or which would compromise informed consent;
  6. a history of attempted suicide (lifetime) and/or suicidal ideation in the past year as assessed by the C-SSRS;
  7. currently on prescription medication that is contraindicated for use with bupropion;
  8. currently using any form of nicotine replacement therapy;
  9. current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV within the past 6 months;
  10. a history of sensitivity to bupropion or nicotine replacement;
  11. any history of seizures or seizure disorder;
  12. a history of serious head injury (ie, loss of consciousness longer than 1 hour, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury
  13. evidence of substance or alcohol dependence in the past six months; evidence of substance or alcohol abuse in the past month;
  14. sedatives or benzodiazepine use within 12 hours of testing based on urine toxicology screening
  15. history of mental retardation or developmental disability based on chart review
  16. psychiatric hospitalization during study participation
  17. history of an eating disorder
  18. have a medical condition that could be made worse by treatment with nicotine, including poorly controlled insulin dependent diabetes, uncontrolled hyperthyroidism, pheochromocytoma, severe oropharyngeal, esophageal, or peptic ulcer disease, or severe renal or hepatic impairment as determined via the baseline medical history and physical exam
  19. have an allergy to adhesive tape or latex or serious dermatologic disease (excluding minor skin conditions such as mild eczema) due to potential for skin allergy to patch
  20. have a known allergy to nicotine or any component of the nicotine patches
  21. be pregnant or sexually active and not using reliable birth control methods consistently (for females)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02676375

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United States, California
West Los Angeles Veterans Affairs Medical Center
Los Angeles, California, United States, 90073
Sponsors and Collaborators
Brentwood Biomedical Research Institute
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Responsible Party: Arthur Brody, Research Psychiatrist, Brentwood Biomedical Research Institute Identifier: NCT02676375    
Other Study ID Numbers: 0024
First Posted: February 8, 2016    Key Record Dates
Results First Posted: July 30, 2019
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors